DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claim 11 is currently withdrawn.
Claims 1-4,6-10 and 12-18 and 20-21 are under current examination to the extent of the elected species of a composition comprising the following ingredients: biofilm neutralizers: sugar alcohol of xylitol; Antifungals: sea salt, tea tree oil, grapefruit seed extract, colloidal silver; Skin soothing agents: aloe vera, methylsulfonylmethane, essential oil, allantoin; Miscellaneous ingredients: and purified water.
Examiner notes that claims 20-21 are hereby rejoined due to amendment to the claims which render them commensurate in scope with the elected species.
Applicants' amendment and remarks filed on 05/26/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statement
Information Disclosure Statement (IDS) filed on 02/11/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
New rejections based on amendment to claims 1 and rejoined claim 20
Claim Rejections - 35 USC § 112(b)-indefinite
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the oils” in line 6. There is insufficient antecedent basis for this limitation in the claim because it is unclear if “the oils” is referring to the tea tree oil, the rosemary essential oil or both. Claim 21 depends from claim 20 and does not rectify the indefinite issue of claim 20.
Claim Rejections - 35 USC § 112(d)-failure to further limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 and 12 recite wherein the oil includes an essential oil, however claim 1 and claim 9 already includes rosemary essential oil. Claims 6 and 12 appears to broaden the rosemary essential oil now to any essential oil. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Rejection maintained and rejoined with claims 20-21
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4,6-10 and 12-18 and rejoined claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Scholz et al. (United States Patent Publication 20180207122) in view of Bhushan et al. (United States Patent Publication 2017/0215417), DiLeva (United States 7691419) and Garrett (United States Patent 9511034).
Claim interpretation: The instant claims are being examined to the extent of the elected species to a composition which comprises the following ingredients together: biofilm neutralizers: sugar alcohol of xylitol; Antifungals: sea salt, tea tree oil, grapefruit seed extract, colloidal silver; Skin soothing agents: aloe vera, methylsulfonylmethane, essential oil, allantoin; purified water.
Claim 1 recites a composition for treating skin of a patient, the composition comprising: a biofilm neutralizer including a sugar alcohol; an antifungal including grapefruit seed extract; and skin soother including aloe vera, MSM and an oil, the oil only having a fatty acid chain length of less than C12 or greater than C24 the oil including rosemary essential oil. The essential oil of claim 1 having C12 or less is being interpreted as the elected tea tree oil which does not contain any fatty acid chain length. The recitation of a fatty acid chain length of less than C12 is inclusive of essential oils that do not contain any fatty acid chains. Applicants elected a further essential oil to be part of the composition which as evidenced by the specification at page 11 is inclusive of rosemary oil. Rosemary oil also does not contain any fatty acid chain lengths, thus meets the claim of less than C12. Note that claim 6 recites that the oil of claim 1 is inclusive of essential oils.
Scholz et al. teach skin care compositions useful in treating infection, thus meeting the intended use of the instant claims for treating skin of a patient, see paragraphs [0019] and [0376]. The composition includes an antimicrobial component comprising the antiseptic of silver colloid, see paragraph [0038], [0134], and [0190]. The colloidal silver antiseptic can be present in at least 0.20% by weight and less than 10% by weight, see paragraph [0193]. This recitation of colloidal silver overlaps and renders obvious the claimed range from 7-12% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The composition can include one or more sugar alcohols to enhance the antimicrobial activity including xylitol present from up to 20% by weight, see paragraphs [0208] and [0244]-[0245]. The xylitol amount overlaps and renders obvious the claimed range of from 0.001-90% by weight. The antiseptic is inclusive of mixtures of antiseptics such as natural oils, see paragraph [0134]-[0135]. Natural antiseptics preferably include a mixture of tea tree oil (essential oil with no fatty acid chains) and grapefruit seed extract, see paragraph [0203] and antiseptics are added to the composition in amounts from 0.1 to 30% by weight, see paragraph [0205]. The compositions treat fungus and bacteria, see paragraph [0110]. The composition is capable of controlling biofilm, see paragraph [0268]. The composition can further include anti-inflammatory agents, excipients, lubricants, preservatives, antioxidants, flavorant or stabilizers, see paragraph [0293]. The formulation can comprise saline, see paragraph [0103]. Water can be present at up to 20% or more, see paragraph [0131]. This amount for water overlaps and renders obvious a range of 50-60% weight since 20% or more is inclusive of 20-100% by weight. The water source is inclusive of distilled water, see paragraph [0393] and furthermore purified (i.e. distilled) water is obvious to obtain a skin treatment formulation free of contaminants.
Scholz et al. does not expressly teach the inclusion of methylsulfonylmethane (MSM).
Bhushan et al. teach antimicrobial compositions for eliminating biofilm on skin which comprise methylsulfonylmethane (MSM) and EDTA, see paragraph [0002] and [0030] and [0081]. The MSM acts as an anti-inflammatory and analgesic and is present from 0.1-40% by weight, see paragraph [0093].
It would have been prima facie obvious before the effective filing date of the claimed invention to incorporate methylsulfonylmethane (MSM) as the anti-inflammatory agent of Scholz in amounts from 0.1-40% by weigh of the antimicrobial composition.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Scholz et al. teach the inclusion of anti-inflammatory agents and MSM is taught to provide analgesic and anti-inflammatory properties to a skin surface. This amount overlaps and renders obvious a claimed range of 4-7% by weight of MSM. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Neither Scholz et al. nor Bhushan et al. teach the presence of rosemary oil essential oil, aloe vera and allantoin wherein the oil is 0.01-0.11 percent of the overall weight, and aloe vera is 0.001-90% by weight.
DiLeva teaches a topical composition for treating skin which includes a mixture of aloe vera, grapeseed oil, eucalyptus and rosemary oil and shea butter, see abstract and claim 1. The rosemary oil can be present from 0-40% weight per volume, and since the composition contains water as the vehicle for a carrier the rosemary can be present from 0-40% by weight, see claim 1, column 5 at line 62 and claim 6, line 5. The aloe vera can be present from 0.01-20% by weight per volume, see claim 1. Since the composition includes water as the liquid carrier the weight percent can comprise from 0.01-20% by weight. The composition treats skin conditions including microbial infections, see abstract. Aloe vera is effective in treating wounds and skin infections, see column 2 at lines 47-55. The rosemary oil provides analgesic and astringent properties, see column 3, lines 12-20. Allantoin and aloe vera provide soothing skin properties, see column 9, lines 37-33 and column 2 lines 47-55. The composition treats wounds infected with bacteria or fungus, see Examples 5 and 7.
It would have been prima facie obvious to provide the skin treating antimicrobial composition of Scholz et al. with a topical composition that comprises, rosemary oil, aloe vera and allantoin.
One of ordinary skill in the art would have been motivated to do so because DiLeva teaches skin care products with comprise rosemary, aloe vera, and allantoin help treat and heal wounds infected with bacteria or fungus. The addition of rosemary imparts analgesic properties while the addition of allantoin and aloe vera helps impart skin soothing properties to the topical product.
There would have been a reasonable expectation of success given both Scholz et al. and Di Leva teach treatment of skin infections.
Neither Scholz et al., Bhushan or DiLeva expressly teach that the topical product contains sea salt.
However, Garrett teaches skin treatment compositions which contain antiseptics, see abstract, column 7 lines 51-53 and 60 . Examples of antiseptic compounds include tea tree oil, see column 18, lines 56-58. The composition includes sea salt which is useful as a skin softener compound, see column 20 lines 14-15, and column 30 lines 17-18.
It would have been prima facie obvious to include sea salt with the topical formulations of Scholz et al. with the motivation of imparting skin softening properties to the topical product.
There would have been a reasonable expectation of success because Scholz et al. teach that the topical skin treating formulation can further include excipients, and both Scholz and Garret teach skin treating compositions which comprise antiseptic compounds.
Regarding the amount of grapefruit seed, Scholz et al. teach addition of antiseptic from 0.1-30% by weight. This amount overlaps and renders obvious the clamed range of 0.1-2% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Regarding the amount of rosemary oil, DiLeva teaches amounts from 0-40% by weight which overlaps the claimed range. Regarding the amount of the oils, Di Leva suggests from 0-40% by weight rosemary with Scholz teaching antiseptic can be present from 0.1-30% by weight. These amounts overlap the claimed range of oils from 0.01-0.11% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the amount of aloe vera DiLeva teaches an amount of from 0.01-20% by weight. This amount overlaps and renders obvious the claimed amount from 0.001-90% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)Furthermore, one of ordinary skill in the art would have been motivated to adjust the concentration of aloe to the dried amount to impart healing properties to the skin as suggested by DiLeva.
Response to Remarks
Applicant argues that the Patent Office contends that methylsulfonylmethane (MSM) as an anti- inflammatory and analgesic and is present from 0.1-40% by weight, and cites to paragraph [0093] of Bhushan. Similarly, the Patent Office states that DiLeva teaches a mixture including rosemary oil, where the rosemary oil provides analgesic and astringent properties, see column 3, lines 12-20 of DiLeva. However, the MSM already has analgesic properties (as contended by the Patent Office) and the aloe vera provides astringent properties (as known in the art). Therefore, a PHOSITA would not seek to add rosemary oil for these properties, as they are redundant with the existing ingredients. Similarly, the Patent Office contends that sea salt can be added to the combination from Garrett because it is useful as a skin softener compound. However, aloe vera and MSM are highly effective as skin softeners (as known in the art). Therefore, a PHOSITA would not seek to add sea salt for these properties, as they are redundant with the existing ingredients. Therefore, Applicant notes that the motivations to combine the references to include rosemary oil and sea salt are redundant and improper.
Examiner respectfully submits that one of ordinary skill in the art would have been motivated to provide MSM for its analgesic and anti-inflammatory properties and rosemary for its analgesic properties because per the teachings of Scholz, additional analgesics or anti-inflammatory agents can be provided with their composition, see paragraph [0293]. The composition of Scholz is not limited to just one analgesic or anti-inflammatory agent. Aloe vera is effective in treating wounds and skin infections, see column 2 at lines 47-55. The rosemary oil provides analgesic and astringent properties, see column 3, lines 12-20. Allantoin and aloe vera provide soothing skin properties, see column 9, lines 37-33 and column 2 lines 47-55. Allantoin and aloe vera provide soothing skin properties, see column 9, lines 37-33 and column 2 lines 47-55 and such compositions treats wounds infected with bacteria or fungus, see Examples 5 and 7. Examiner notes that although MSM and rosemary both provide astringent properties, the astringent in Scholz is not limited to one. Regarding the fact that sea salt and MSM or aloe may also be known elsewhere in the art as skin softeners, It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). Combining art recognized ingredients which have the same properties is considered prima facie obvious absent evidence to the contrary.
Applicant argues that the office has used impermissible hindsight to arrive at the instantly claimed invention.
Examiner respectfully submits that In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Applicant’s arguments/remarks are considered unpersuasive and the amendment to the claims necessitated new grounds of rejections. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Currently no claims are allowed and claims 1-10 and 12-18 and 20-21 are rejected.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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